REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03460548
Recruitment Status : Not yet recruiting
First Posted : March 9, 2018
Last Update Posted : March 9, 2018
Information provided by (Responsible Party):
TRB Chemedica

Brief Summary:
The efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.

Condition or disease Intervention/treatment Phase
Dry Eye Device: Remogen Device: Cationorm Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Arm Intervention/treatment
Experimental: Remogen Device: Remogen
instil 1 drop of the product in each eye, 4 times per day

Active Comparator: Cationorm Device: Cationorm
instil 1 drop of the product in each eye, 4 times per day

Primary Outcome Measures :
  1. OSSF [ Time Frame: Day 28 ]
    Ocular surface staining with fluorescein (OSSF)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • With at least a 3-month documented history of bilateral dry eye
  • With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
  • With at least one objective sign of tear deficiency
  • With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion Criteria:

  • Refractive surgery within 12 months prior to selection
  • Any other ocular surgery or ocular trauma within 6 months prior to selection
  • Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

Responsible Party: TRB Chemedica Identifier: NCT03460548     History of Changes
Other Study ID Numbers: TOGA-CT-1501
First Posted: March 9, 2018    Key Record Dates
Last Update Posted: March 9, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Keratoconjunctivitis Sicca
Dry Eye Syndromes
Conjunctival Diseases
Eye Diseases
Corneal Diseases
Lacrimal Apparatus Diseases
Plasma Substitutes
Blood Substitutes